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Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer

Study acronym: ReaLuP
StatusRecruiting
PhasePhase 2
Started2025-04-11
View on ClinicalTrials.gov ↗

Amendment history

2026-01-02
Study Status, Study Description, Eligibility, Contacts/Locations v2
Study sites13→16
Eligibility criteria+153 characters
[...] including radiological, clinical but also PSA progression). (Patients with a radiological or clinical progressive disease during the first 120 days after the last cycle of the first course of [177Lu]Lu-PSMA are not eligible. PSA progression is defined by a ≥ 25% increase in PSA and an absolute increase of 2 ng/mL or more from the NADIR and confirmed by a sec [...] Participants must have been previously treated with at least [...] ne taxane based chemotherapy (with docetaxel or cabazitaxel) (The number of previously administrated lines of taxane-based therapy is not limited ; patients can have received a tax [...] [...]
2025-05-20
Not Yet Recruiting→Recruiting Study Identification, Study Status, Outcome Measures, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-04→confirmed 2025-04-11
Secondary endpointsdetails revised at 2 of 12 entries
Study sitesdetails revised at 13 of 13 sites
Study title-10 characters
Phase IIb Study of Re-treatment With [177Lu]Lu-PSMA in Men With Metastatic Castration Resistance Prostate Cancer
2025-03-04
Original filing
Prostate cancer is the third leading cause of cancer-related death in men in the United States and Europe. The treatment of metastatic castration-resistant prostate cancer (mCRPC) has evolved with the arrival of the radioligand \[177Lu\]Lu-PSMA-617, which specifically targets PSMA-expressing cancer cells. The randomized phase III VISION study showed that \[177Lu\]Lu-PSMA-617 significantly improved progression-free survival and overall survival with an acceptable toxicity profile. The ReaLuP study will evaluate the efficacy of a re-treatment of \[177Lu\]Lu-PSMA-617 in patients with progressive PSMA-positive mCRPC and who have been previously treated with \[177Lu\]Lu-PSMA without evidence of progression during this first course of treatment. Patients will be treated until disease progression, unacceptable toxicity or death, or alternatively up to 9 months after the last dose of treatment. At the end of this follow up period, patients will enter the " long term follow up ", at least for 2 years after the end of the last active follow-up.
Trial Details
NCT Number NCT06866938
Lead Sponsor Hospices Civils de Lyon
Conditions Metastatic Castration-resistant Prostate Cancer
Enrollment 58 participants
Start Date 2025-04-11
Primary Completion 2027-04 (estimated)
Study Completion 2030-04 (estimated)
Updated on ClinicalTrials.gov 2026-01-06